U.S. patent application number 09/764218 was filed with the patent office on 2002-07-18 for incision tensioning system and method for using the same.
Invention is credited to Bombard, David, Chang, Tenny, Vargas, Jaime.
Application Number | 20020095166 09/764218 |
Document ID | / |
Family ID | 25070029 |
Filed Date | 2002-07-18 |
United States Patent
Application |
20020095166 |
Kind Code |
A1 |
Vargas, Jaime ; et
al. |
July 18, 2002 |
Incision tensioning system and method for using the same
Abstract
A method for tensioning incisions made in a target vessel during
an anastomosis procedure is provided. After an incision is made in
a target vessel, incision tensioners are placed within the incision
in order to tension the incision. The incision is tensioned when
the incision tensioners are pulled taut in order to stretch the
incision to a predetermined length or a predetermined force. The
tensioners allow for proper grafting of a graft vessel to the
target vessel in an end to side anastomosis. In addition, the
incision tensioners allow the incision to have a known geometry,
thereby allowing precise grafting of the graft vessel to the target
vessel during the anastomosis procedure. After the incision is
tensioned, the graft vessel is grafted to the target vessel using
clips, sutures, staples or other anastomosis devices. One example
of anastomosis clips are configured to capture the graft vessel and
the target vessel such that the graft vessel grafts with the target
vessel.
Inventors: |
Vargas, Jaime; (Palo Alto,
CA) ; Chang, Tenny; (Mountain View, CA) ;
Bombard, David; (San Francisco, CA) |
Correspondence
Address: |
BRIAN A. SCHAR
VASCULAR INNOVATIONS, INC.
171 JEFFERSON DRIVE
MENLO PARK
CA
94025
US
|
Family ID: |
25070029 |
Appl. No.: |
09/764218 |
Filed: |
January 16, 2001 |
Current U.S.
Class: |
606/150 ;
606/153 |
Current CPC
Class: |
A61B 17/0218 20130101;
A61B 2017/1135 20130101; A61B 2017/1107 20130101; A61B 17/11
20130101 |
Class at
Publication: |
606/150 ;
606/153 |
International
Class: |
A61B 017/04 |
Claims
What is claimed:
1. A method for grafting a graft vessel to a target vessel during
an anastomosis procedure, the method comprising: forming an
incision in the target vessel; placing incision tensioners within
the incision in the target vessel; tensioning the incision in the
target vessel with the incision tensioners; and grafting the graft
vessel to the target vessel while the incision is tensioned.
2. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the incision tensioners are pins.
3. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the incision tensioners are hooks.
4. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the incision tensioners include a
cutting surface configured to form the incision within the target
vessel.
5. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the incision tensioners are
sutures.
6. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the incision tensioners each include a
balloon assembly configured to provide tension on the incision in
the target vessel.
7. A method for grafting a graft vessel to a target vessel as
recited in claim 6, wherein the balloon assemblies each include a
balloon.
8. A method for grafting a graft vessel to a target vessel as
recited in claim 7, wherein each balloon is uninflated prior to
placement within the target vessel.
9. A method for grafting a graft vessel to a target vessel as
recited in claim 8, the method further comprising: inflating the
balloon after the balloon is inserted within the target vessel; and
tensioning the incision by pulling the balloon assemblies away from
one another.
10. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the incision is tensioned to a
predetermined length which corresponds to a size of the graft
vessel to be grafted to the target vessel during the anastomosis
procedure.
11. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the operation of tensioning the
incision in the target vessel further comprises: pulling the
incision tensioners with a predetermined force.
12. A method for grafting a graft vessel to a target vessel as
recited in claim 11, wherein the predetermined force is in a range
of about 0.001 N to about 4.5 N.
13. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the incision tensioners are clips which
include a first tine and a second tine.
14. A method for grafting a graft vessel to a target vessel as
recited in claim 13, wherein both the first tine and the second
tine are configured to penetrate both the graft vessel and the
target vessel.
15. A method for grafting a graft vessel to a target vessel as
recited in claim 14, wherein both the first tine and the second
tine are configured to rotate such that the first tine and the
second tine capture the graft vessel and the target vessel.
16. A method for grafting a graft vessel to a target vessel as
recited in claim 14, wherein both the first tine and the second
tine are configured to fold over such that the first tine and the
second tine capture the graft vessel and the target vessel.
17. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the incision tensioner is an anvil
configured to tension the incision in the target vessel.
18. A method for grafting a graft vessel to a target vessel as
recited in claim 1, wherein the tensioning of the incision allows a
geometry of the incision in the target vessel to remain constant
during the anastomosis procedure.
19. A method for forming an incision in a target vessel for an
anastomosis procedure, the method comprising: inserting a first
incision tensioner and a second incision tensioner through a wall
of the target vessel; and separating the first incision tensioner
from the second incision tensioner to tension an incision in the
target vessel.
20. A method for forming an incision in a target vessel as recited
in claim 19, wherein the incision tensioners remain in the incision
in the target vessel during the anastomosis procedure to maintain a
known geometry of the incision.
21. A method for forming an incision in a target vessel as recited
in claim 20, wherein the known geometry allows the incision in the
target to vessel to remain constant during the anastomosis
procedure.
22. A method for forming an incision in a target vessel as recited
in claim 19, wherein the second incision tensioner includes a
cutting surface configured to form the incision in the target
vessel.
23 A method for forming an incision in a target vessel as recited
in claim 19, wherein the incision tensioners are pins.
24. A method for forming an incision in a target vessel as recited
in claim 19, wherein the incision tensioners are hooks.
25. A method for forming an incision in a target vessel as recited
in claim 19, wherein the incision tensioners form an incision
having a predetermined length which corresponds to a size of a
graft vessel to be grafted to the target vessel during the
anastomosis procedure.
26. A system for aligning a graft vessel to a target vessel having
an incision formed therein, the system comprising: first and second
incision tensioners configured for placement within the incision of
the target vessel, where the incision tensioners are configured to
tension the incision to a predetermined length having a known
geometry; a tensioning device body connected to the incision
tensioners; and a tensioning mechanism for moving the first
incision tensioner with respect to the second incision
tensioner.
27. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the tensioning mechanism includes a
tension spring for moving the first incision tensioner with respect
to the second incision tensioner.
28. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the tensioning mechanism includes a
threaded assembly for moving the first incision tensioner with
respect to the second incision tensioner.
29. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the incision tensioners are configured
to form the incision of the target vessel.
30. A system for aligning a graft vessel to a target vessel as
recited in claim 29, wherein the first incision tensioner includes
a cutting surface configured to form the incision.
31. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the predetermined length corresponds
to a size of the graft vessel to be grafted to the target vessel
during the anastomosis procedure.
32. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the incision tensioners are hooks.
33. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the incision tensioners are pins.
34. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the incision tensioners are
sutures.
35. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the incision tensioners each include a
balloon assembly configured to tension the incision of the target
vessel.
36. A system for aligning a graft vessel to a target vessel as
recited in claim 35, wherein the balloon assemblies each include a
balloon.
37. A system for aligning a graft vessel to a target vessel as
recited in claim 36, wherein each balloon is uninflated prior to
placement within the target vessel.
38. A system for aligning a graft vessel to a target vessel as
recited in claim 37, wherein the balloon is inflated after the
balloon is placed within the incision.
39. A system for aligning a graft vessel to a target vessel as
recited in claim 38, wherein the tensioning mechanism moves the
first incision tensioner with respect to the second incision
tensioner after each of the balloons are inflated.
40. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the tensioning mechanism moves the
first incision tensioner with respect to the second incision
tensioner using a predetermined force.
41. A system for aligning a graft vessel to a target vessel as
recited in claim 40, wherein the predetermined force is in a range
of about 0.001 N to about 4.5 N.
42. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the incision tensioners are incision
tensioner clips which includes a first tine and a second tine.
43. A system for aligning a graft vessel to a target vessel as
recited in claim 42, wherein both the first tine and the second
tine are configured to penetrate the graft vessel and the target
vessel.
44. A system for aligning a graft vessel to a target vessel as
recited in claim 43, wherein both the first tine and the second
tine are configured to rotate such that the first tine and the
second tine capture the graft vessel and the target vessel.
45. A system for aligning a graft vessel to a target vessel as
recited in claim 43, wherein both the first tine and the second
tine are configured to fold over such that the first tine and the
second tine capture the graft vessel and the target vessel.
46. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the incision tensioners maintain the
known geometry of the incision during an anastomosis procedure.
47. A system for aligning a graft vessel to a target vessel as
recited in claim 26, wherein the known geometry allows the incision
in the target to vessel to remain constant during the anastomosis
procedure.
48. A tension control device for aligning a graft vessel to a
target vessel having an incision formed therein during an
anastomosis procedure, the tension control device comprising a
first tensioner slidably coupled with a second tensioner, where the
tensioners are configured to tension the incision formed in the
target vessel with a predetermined force imparted to the tensioners
with a force applying mechanism.
49. A tension control device as recited in claim 48, wherein the
tension control device forms the incision in the target vessel to a
known geometry.
50. A tension control device as recited in claim 49, wherein the
known geometry allows the incision in the target to vessel to
remain constant during the anastomosis procedure.
51. A tension control device as recited in claim 48, wherein the
force applying mechanism is a spring.
52. A tension control device as recited in claim 48, wherein the
first tensioner couples with the second tensioner using a
notch.
53. A tension control device as recited in claim 48, wherein the
first tensioner and the second tensioner include removable portions
in order to facilitate grafting of the graft vessel to the target
vessel during the anastomosis procedure.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates generally to preparing blood
vessels for a vascular anastomosis procedure and more particularly
to a system and method for forming and holding precise incisions in
a target vessel.
[0003] 2. Description of Related Art
[0004] Vascular anastomosis is a procedure where two separate blood
vessels of a patient are surgically grafted together. The vascular
anastomosis procedure is routinely performed during the treatment
of a variety of conditions, including coronary artery disease,
diseases of the great and peripheral vessels, organ transplantation
and other types of trauma. When a patient suffers from coronary
artery disease (CAD), an occlusion or stenosis in a coronary artery
restricts blood flow to the heart muscle. In order to treat CAD,
the area where the occlusion occurs is bypassed. The area is
bypassed through rerouting blood flow by grafting a vessel in the
form of either a prosthesis, a harvested artery or a vein. When the
vessel is grafted to bypass the blocked coronary artery, the
occlusion is avoided and adequate blood flow is restored to the
heart muscle. This treatment is known as coronary artery bypass
grafting (CABG).
[0005] When a CABG is performed, a large incision is made in the
chest of a patient and the sternum is separated in order to allow
access to the heart of the patient. Moreover, the patient is
connected to a heart lung machine which circulates the blood of the
patient. After the heart lung machine is connected to the patient,
the patient's heart is stopped in order to perform the vascular
anastomosis. However, stopping the patient's heart is very
traumatic to the patient.
[0006] In order to minimize the trauma to the patient induced by
the CABG, less invasive techniques have been used. These less
invasive techniques include performing a series of small incisions
in the patient's chest. Once the incisions are completed, surgery
is performed with the aid of visualizing scopes. The less invasive
techniques may be performed on a beating heart in order minimize
trauma to the patient, thereby avoiding the need for
cardiopulmonary bypass.
[0007] In both the conventional and less invasive CABG techniques,
a surgeon makes an incision in a coronary artery in order to allow
grafting of a graft vessel to the coronary artery. However, as the
surgeon makes an incision in the coronary artery, an incision
without a definable geometry results, as shown with respect to FIG.
1. FIG. 1 is a schematic of a top view of a coronary artery 102
after the formation of an incision by a surgeon in accordance with
the prior art. During both the conventional and less invasive CABG
techniques, a surgeon forms an incision 104 in the coronary artery
102 as shown with respect to FIG. 1. As those skilled in the art
will appreciate, the incision 104 includes walls 104a and 104b
which do not define a geometry. The imprecise geometry of the
incision 104, as illustrated by the walls 104a and 104b, make
grafting a graft vessel to the coronary artery 102 difficult.
[0008] In addition, as may be seen with respect to FIG. 1, the
incision 104 is not held in place. Instead, the geometry of the
incision 104 is dictated by the orientation of the coronary artery
102. To further illustrate, if the coronary artery 102 shifts
during an anastomotic procedure, the geometry of the incision 104
changes, thereby making grafting even more difficult. As a result,
suturing a graft vessel to the coronary artery requires a greater
amount of time and surgical skill, thereby increasing the overall
cost to perform an anastomotic procedure.
[0009] Furthermore, once the surgeon makes the incision 104 in the
coronary artery 102, the surgeon must suture a graft vessel to the
coronary artery 102. Typically, the surgeon sutures the graft
vessel to the coronary artery by hand sewing the vessel using a
needle the size of an eyelash. As may be appreciated, this
technique requires a great amount of skill on the part of the
surgeon and a great amount of time. Thus, both the time and
financial costs are greatly increased for the patient. In addition,
during both the conventional techniques and the less-invasive
techniques, the possibility of trauma to the patient is further
increased due to the greater amount of time required to perform the
surgery.
[0010] In addition to suturing, other methods used during an
anastomosis to graft a graft vessel to a coronary artery involves
the use of an automated anastomosis instrument. However, when an
automated anastomosis instrument is used, accurate location of the
tissue is important to achieve accurate and leak-proof
grafting.
[0011] Accordingly, a need exists for a method to form and hold
incisions having a definable geometry in order to allow precise
grafting of a graft vessel to a target vessel. This new method
should minimize the time associated with grafting a graft vessel to
a target vessel, thereby decreasing the possibility of trauma to a
patient resulting from a long anastomotic procedure. Also, the new
method should minimize the time associated with grafting a graft
vessel to a target vessel by providing both a method allowing
precise incisions in a target vessel and a simplified method for
attaching the graft vessel to the target vessel once the incision
is made.
BRIEF SUMMARY OF THE INVENTION
[0012] The present invention fills the aforementioned needs by
providing a method for tensioning incisions in a target vessel. The
present invention also provides a system for tensioning incisions
in a target vessel such that the incisions have a known geometry
with a predetermined length.
[0013] In one embodiment of the present invention, a method for
grafting a graft vessel to a target vessel during an anastomosis
procedure is disclosed. The method comprises forming an incision in
the target vessel and placing incision tensioners within the
incision. Upon placement of the incision tensioners within the
incision, the incision tensioners tension the target vessel by
pulling the incision taut. Once the incision is tensioned, the
graft vessel is grafted to the target vessel using any suitable
technique, including welding, clips, staples, or the like.
[0014] In a further embodiment of the present invention, a method
for forming an incision in a target vessel for an anastomosis
procedure is disclosed. The method comprises inserting a first
incision tensioner and a second incision tensioner through a wall
of the target vessel. After the incision tensioners are inserted in
the wall of the target vessel, the first incision tensioner is
separated from the second incision tensioner. When the first
incision tensioner is separated from the second incision tensioner,
the incision is tensioned to a predetermined length having a known
geometry.
[0015] In another embodiment of the present invention, a system for
grafting a graft vessel to a target vessel having an incision
formed therein is disclosed. The system comprises first and second
incision tensioners, a tensioning device body and a tensioning
mechanism. The first and second incision tensioners are configured
for placement within the incision of the target vessel. In
addition, the incision tensioners are configured to tension the
incision to a predetermined length having a known geometry once the
incision tensioners are placed within the incision of the target
vessel. The tensioning device body connects to both the first
incision tensioner and the second incision tensioner with the
tensioning mechanism. The tensioning mechanism moves the first
incision tensioner with respect to the second incision tensioner in
order to tension the incision in the target vessel.
[0016] As may be appreciated, the present invention provides a
method for tensioning incisions to a predetermined length in a
target vessel. In addition, the present invention provides a method
for maintaining a known geometry of the incision during an
anastomosis procedure. Therefore, the prior art problems associated
with the an incision having a non-definable geometry are avoided.
Furthermore, the predetermined length and the known geometry of the
incisions allow for precise grafting of a graft vessel to the
target vessel in a time efficient and cost efficient manner.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0017] Many advantages of the present invention will be apparent to
those skilled in the art with a reading of this specification in
conjunction with the attached drawings, wherein like reference
numerals are applied to like elements and wherein:
[0018] FIG. 1 is a schematic top view of a coronary artery after
incision by a surgeon in accordance with the prior art.
[0019] FIG. 2 is a top view of a target vessel after the formation
of an incision, in accordance with one embodiment of the present
invention.
[0020] FIG. 3A is a schematic perspective view of the target vessel
shown with reference to FIG. 2, where the incision is pulled taut
with hooks, in accordance with one embodiment of the present
invention.
[0021] FIG. 3B is a side view of alternative embodiments of the
hooks as shown with reference to FIG. 3A, in accordance with one
embodiment of the present invention.
[0022] FIG. 4A is a schematic perspective view of an embodiment of
the present invention where pins pull the incision shown with
reference to FIG. 3A taut.
[0023] FIG. 4B is a side view of alternative embodiments of pins
which may be used to hold the incision shown with respect to FIG.
4A, in accordance with one embodiment of the present invention.
[0024] FIG. 5A illustrates a schematic perspective view of an
embodiment of the present invention where sutures are used to hold
the incision shown with respect to FIG. 4A to a critical
dimension.
[0025] FIG. 5B is a schematic perspective view of an embodiment of
the present where sutures are used to hold an incision.
[0026] FIG. 6A is a schematic perspective view of an incision where
balloons are used to hold the incision, in accordance with one
embodiment of the present invention.
[0027] FIG. 6B is a side view of a balloon assembly shown with
reference to FIG. 6A, in accordance with one embodiment of the
present invention.
[0028] FIG. 7A is a schematic perspective view of an embodiment of
the present invention where an anvil is used to hold an
incision.
[0029] FIG. 7B is a perspective view of the anvil shown with
respect to FIG. 7A.
[0030] FIG. 8 is a schematic perspective view of the target vessel
shown with reference to FIG. 5A, where a hook includes a cutting
surface, in accordance with one embodiment of the present
invention.
[0031] FIG. 9 is a schematic perspective view of the target vessel
shown with reference to FIG. 8, where the incision has been formed
in the target vessel with the hook, in accordance with one
embodiment of the present invention.
[0032] FIG. 10A is a schematic perspective view of the target
vessel shown with respect to FIG. 9, where a cutting surface
rotates away from the target vessel, in accordance with one
embodiment of the present invention.
[0033] FIG. 10B is a schematic perspective view of the target
vessel shown with reference to FIG. 9, where a cutting surface is
lowered within the target vessel in order to prevent additional
lengthening of the target vessel, in accordance with one embodiment
of the present invention.
[0034] FIG. 11 is a perspective view of an incision tensioning clip
capturing a graft vessel and a target vessel, in accordance with
one embodiment of the present invention.
[0035] FIG. 12 is a perspective view of the target vessel shown
with respect to FIG. 10B, where incision tensioning clips have been
inserted into the target vessel, in accordance with one embodiment
of the present invention.
[0036] FIG. 13 is a perspective view of an embodiment of the
present invention illustrating the target vessel shown with
reference to FIG. 12, where a vessel is grafted to the target
vessel during an anastomosis procedure using the incision
tensioning clips.
[0037] FIG. 14A is a perspective view illustrating a force
controlled tension device, in accordance with one embodiment of the
present invention.
[0038] FIG. 14B illustrates a perspective view of the force
controlled tension device shown with reference to FIG. 14A, where
the force controlled tension device is configured for insertion
into a target vessel.
[0039] FIG. 15A is a schematic perspective view of the force
controlled tension device shown with respect to FIG. 14A forming an
incision in a target vessel, in accordance with one embodiment of
the present invention.
[0040] FIG. 15B is an embodiment of the present invention showing
the force controlled tension device shown with reference to FIG.
15A, where the force controlled tension device forms an incision in
a target vessel to a predetermined length X.
[0041] FIG. 16 is a flow chart illustrating a method for incision
tensioning a target vessel, in accordance with one embodiment of
the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0042] A method for tensioning an incision on a target vessel
during an anastomosis procedure is disclosed. The incision is
tensioned in a target vessel in order to facilitate grafting of a
vessel to the target vessel during the anastomosis procedure.
Furthermore, the tensioned incision allows for proper aligning of a
graft vessel with a target vessel. As used herein, an incision is
tensioned when the incision is pulled taut. In accordance with
another embodiment of the present invention, the incision may also
be tensioned by stretching the incision with incision tensioners.
The incision is pulled taut when the edges of the incision are
substantially straight and parallel to one another, as will be
described in much greater detail with respect to accompanying
Figures. In addition, as will be further described with reference
to the accompanying Figures, the incision tensioners may be any
device suitable for pulling an incision taut, such as hooks, pins
or the like.
[0043] Now making reference to the Figures, and more particularly
to FIG. 2, FIG. 2 is a top view of the target vessel 202 after the
formation of the incision 204. The incision 204 is formed in order
to allow the grafting of a graft vessel (shown in FIG. 13) to the
target vessel 202 at the point of the incision 204 in an end to
side anastomosis. The incision 204 is formed using any suitable
technique, such as punching a hole, or slicing with a scalpel,
knife, shears or the like. Once the incision 204 is formed, the
incision 204 is pulled taut as shown with reference to FIG. 3A.
[0044] FIG. 3A is a schematic showing a perspective view of the
target vessel 202 shown with reference to FIG. 2, where the
incision 204 is tensioned with an incision tensioning system 200.
In one embodiment of the present invention, the incision tensioning
system 200 aligns a graft vessel (shown with reference to FIG. 13)
with the target vessel 202. The incision tensioning system 200
includes tensioners 222, a bracket 216 and hooks 206a. The
tensioners 222 provide a force to the hooks 206a such that the
hooks 206a tension the incision 204. In accordance with one
embodiment of the present invention, the tensioners 222 may be any
device suitable for providing a tensioning force on the hooks 206A
such as a spring, a threaded fastener, or the like. The bracket 216
provides structural support for the tensioners 222 and the hooks
206a such that the tensioners 222 provide a tensioning force to the
hooks 206a in order to tension the incision 204.
[0045] The hooks 206a are inserted into ends of the incision 204,
as shown with reference to the Figure. The hooks 206a are
configured to engage the ends of the incision 204 such that the
hooks 206a pull the incision 204 taut to form a known geometry in
which the sides of the incision 204 are substantially straight and
parallel, as shown with respect to FIG. 3A. In accordance with one
embodiment of the present invention, the known geometry is defined
as the ability of the geometry of the incision 204 to remain
constant during an anastomosis procedure. As described with
reference to the prior art of FIG. 1, the prior art incisions
formed in a target vessel were not pulled taut and did not have a
known geometry. Therefore, the geometry of the prior art incision
changes as a surgeon performs an anastomosis procedure, as opposed
to the present invention.
[0046] In accordance with an embodiment of the present invention,
the incision 204 is taut when the incision 204 is tensioned to a
predetermined length X. The predetermined length X of the incision
204 corresponds to a width of a compressed graft vessel (shown with
reference to FIG. 13) to be grafted to the target vessel 202 during
the anastomosis procedure. When the incision 204 is tensioned to
the predetermined length X, proper grafting of the graft vessel to
the target vessel 202 is ensured. In one embodiment of the present
invention, the incision 204 is tensioned by preferably stretching
in a range between about 2% of the length of the incision 204 to
about 25% of the length of the incision 204. For example, if the
incision 204 has a predetermined length of 0.200 inches, the
incision 204 is tensioned when the hooks 206a stretch the incision
to a predetermined length of 0.220 inches. Additionally, in
accordance with another embodiment of the present invention, the
hooks 206a may be pulled with a predetermined force as denoted by
directional arrows Y and Z. In one embodiment of the present
invention, the pre-determined tensioning force is in a range
preferably of about 0.001 N to about 4.5 N and more preferably
about 0.65 N. Incision tensioning is provided by pulling on the
hooks 206a until the incision 204 is tensioned to the predetermined
length X. The incision may be measured using any suitable technique
to ascertain the proper length.
[0047] It should be noted that the hooks 206a may have any
configuration suitable for engaging ends of the incision 204, as
shown with reference to FIG. 3B. FIG. 3B is a side view of
alternative embodiments of the hooks 206a as shown with reference
to FIG. 3A, in accordance with one embodiment of the present
invention. Hooks 206a, 206b and 206c include ends 206a-1, 206b-1
and 206c-1. The ends 206a-1, 206b-1 and 206c-1 are configured to
engage the incision 204 once the hooks 206a, 206b and 206c are
inserted in the incision 204, as shown with reference to FIG. 3A.
Therefore, after the hooks 206a, 206b and 206c are inserted in the
incision 204, the ends 206a-1, 206b-1 and 206c-1 engage tissue to
pull the incision 204 taut. In addition to the hooks 206a, 206b and
206c, pins 208a may also be used to pull the incision 204 taut, as
shown with reference to FIG. 4A.
[0048] FIG. 4A is a side view of the incision 204 shown with
reference to FIG. 3A, where the pins 208a are inserted in the
incision 204 to tension the incision 204, in accordance with one
embodiment of the present invention. As described with reference to
FIG. 3A, the pins 208a tension the incision 204 by pulling the
incision 204 taut using the tensioners 222 until the incision 204
is tensioned to the predetermined length X. Alternatively, the pins
208a may be pulled with a pre-determined force along the
directional arrows Y and Z, as described with reference to FIG. 3A.
In addition to the pins 208a, any pin having a configuration
suitable for pulling the incision 204 taut may be used to stretch
the incision 204 to the predetermined length X, as shown with
respect to FIG. 4B.
[0049] FIG. 4B shows pins 208a, 208b and 208c which may be used to
tension the incision 204 to the predetermined length X, in
accordance with one embodiment of the present invention. The pins
208b and 208c include ends 208b-1 and 208c-1. The end 208b-1
includes a groove 208b-2 which is configured to engage the incision
204 as the pin 208b is inserted into the incision 204. The end
208c-1 is configured to engage the incision 204 as the pin 208c is
inserted into the incision 204. In addition to the pins 208a
through 208c, sutures 210a may be used to tension the incision 204
to the predetermined length X, as shown with reference to FIGS. 5A
and 5B.
[0050] FIG. 5A illustrates a side view of the incision 204 shown
with respect to FIG. 4A, where the sutures 210a tension the
incision 204 to the predetermined length X. In this embodiment, the
sutures 210a include ends 210a-1 which are attached to the ends of
the incision 204 and knotted in a conventional manner as shown with
respect to FIG. 5A. Once the sutures 210a are formed, the sutures
210a pull the incision 204 taut in order to tension the incision
204. In addition to the knotted sutures 210a, unknotted sutures
210b, as shown with respect to FIG. 5B, may also be used to tension
the incision 204 to the predetermined length X.
[0051] FIG. 5B illustrates a side view of the incision 204 shown
with respect to FIG. 4A, where the sutures 210b are used to tension
the incision 204 to the predetermined length X. In this embodiment,
the sutures 210b are formed such that the sutures 210b stet through
ends of the incision 204, as shown with reference to FIG. 5B. Once
the sutures 210b are secured to the ends of the incision 204, the
sutures are pulled taut to tension the incision 204 to the
predetermined length X. In addition to the sutures 210a and 210b, a
balloon assembly 212 may be used to tension the incision 204 to the
predetermined length X, as shown with respect to FIG. 6A.
[0052] FIG. 6A shows a side view of the incision 204 shown with
reference to FIG. 5B, where the balloon assembly 212 tensions the
incision 204 to the predetermined length X. The balloon assembly
212 includes a balloon 212a rigidly coupled with a member 212b, as
shown with reference to FIG. 6B. When the balloons assemblies 212
are inserted into the incision 204, the balloons 212a are in an
uninflated configuration in order to facilitate placement within
the incision 204. Once the balloons 212a are placed within the
incision 204, the balloons 212a are inflated using any suitable
technique. Upon inflation, the balloon assemblies 212 are used to
tension the incision 204. The balloon assemblies 212 tension the
incision 204 by pulling the balloon assemblies 212 taut within the
incision 204 to tension the incision 204 into the predetermined
length X, as shown with respect to FIG. 6A. It should also be noted
that the balloon assemblies 212 may tension the incision 204 to the
predetermined length X with the predetermined force, as previously
described.
[0053] In addition to the balloons 212a, a member 214 may also be
used to tension the incision 204 to the predetermined length X, as
shown with reference to FIG. 7A. Once the incision 204 is made, the
member 214 is placed within the incision 204 in order to tension
the incision to the predetermined length X, as shown with respect
to FIG. 7A. The member 214 includes an anvil 214a (shown with
reference to FIG. 7B) which is configured for insertion in the
incision 204 in order to tension the incision 204 to the
predetermined length X. Thus, upon placement of the member 214
within the incision 204, the anvil 214a tensions the incision 204
to the predetermined length X.
[0054] As previously stated, the incision 204 is formed using any
suitable technique, such as slicing with a scalpel, knife, shears
or the like. Nonetheless, in accordance with another embodiment of
the present invention, the incision 204 may be tensioned by a hook
206a' configured to include a cutting surface 206a'-2, as shown
with reference to FIG. 8. FIG. 8 is a side view of the target
vessel 202 shown with reference to FIG. 5A, where the hook 206a'
includes the cutting surface 206a'-2, in accordance with one
embodiment of the present invention. The cutting surface 206a'-2 is
configured to form an incision in the target vessel 202 in order to
allow tensioning of the incision 204 to the predetermined length X.
In one embodiment of the present invention, the cutting surface
206a'-2 may be any sharpened surface suitable for forming an
incision in the target vessel 202, including a blade or the like.
Once the hooks 206a and 206a' are inserted into the target vessel
202, the hook 206a' moves away from the hook 206a to form the
incision 204, as shown with reference to FIG. 9.
[0055] FIG. 9 illustrates a side view of the target vessel 202
shown with reference to FIG. 8, illustrating the formation of the
incision 204 in the target vessel 202 with the hook 206a', in
accordance with one embodiment of the present invention. The
cutting surface 206a'-2 forms the incision 204 as the hook 206a'
moves in a direction denoted by the directional arrow Z. After the
incision 204 is formed, the cutting surface 206a'-2 is removed from
an edge of the incision 204, as shown with reference to FIG.
10A.
[0056] FIG. 10A illustrates a side view of the target vessel 202
shown with respect to FIG. 9, where the cutting surface 206a'-2
rotates away from the edge of the incision 204 in order to prevent
further cutting of the incision 204, in accordance with one
embodiment of the present invention. In this embodiment, the
cutting surface 206a'-2 rotatably attaches to the hook 206a' using
any suitable technique, including pins, a bearing assembly, or the
like. After the cutting surface 206a'-2 rotates away from the edge
of the incision 204, the hooks 206a and 206a' tension the incision
204 to the predetermined length X. In addition to rotating the
cutting surface 206a'-2 away from the edge of the incision 204, as
shown with reference to FIG. 10A, the cutting surface 206a'-2 may
be lowered within the target vessel 202 such that the cutting
surface 206a'-2 does not contact the edge of the incision 204, as
shown with respect to FIG. 10B.
[0057] FIG. 10B is a side view of the target vessel 202 shown with
reference to FIG. 10A, where the cutting surface 206a'-2 lowers
within the target vessel 202 upon formation of the incision 204, in
order to prevent additional cutting of the target vessel 202, in
accordance with one embodiment of the present invention. In this
embodiment, the configuration of the hook 206a' allows lowering of
the cutting surface 206a'-2 using any suitable technique, including
a piston-type assembly where the hook 206a' includes a pin 206a'-3
having the cutting surface 206a'-2. In this embodiment, the pin
206a'-3 is configured to slide into and out of a base 206a'-4 of
the hook 206a'. Thus, upon formation of the incision 204, the
piston 206a'-3 lowers the cutting surface 206a'-2 within the target
vessel 202. Upon lowering the cutting surface 206a'-2, the hooks
206a and 206a' tension the incision 204 to the predetermined length
X.
[0058] In addition to the hooks 206a and 206a', the incision 204
may also be tensioned using an incision tensioning clip 218, as
shown with reference to FIG. 11. The incision tensioning clip 218
includes tines 218a and 218b and a body 218c. The tines 218a and
218b are configured to penetrate vessels and rotate or fold over
toward the body 218c upon vessel penetration in order to capture a
vessel, as shown with reference to FIGS. 12 and 13.
[0059] FIG. 12 is a perspective view of the target vessel 202 shown
with respect to FIG. 10B, where the incision tensioning clips 218
have been inserted into the target vessel 202, in accordance with
one embodiment of the present invention. The incision tensioning
clips 218 tension the incision 204 to the predetermined length X
and capture a graft vessel 220 (shown in FIG. 13) with the target
vessel 202. After the incision 204 is formed, the tine 218b of the
incision tensioning clip 218 is inserted within the target vessel
202 such that the incision tensioning clip 218 traps a target
vessel wall of the target vessel 202 between the tine 218b and the
body 218c, as shown with reference to the Figure. Once the incision
tensioning clips 218 are placed within the target vessel 202, the
incision 204 is tensioned and the graft vessel 220 is grafted to
the target vessel 202, as illustrated with reference to FIG.
13.
[0060] FIG. 13 is a perspective view of the target vessel 202 shown
with reference to FIG. 12, where the graft vessel 220 is grafted to
the target vessel 202 during an anastomosis procedure. The graft
vessel 220 is grafted to the target vessel 202 at the incision 204
using the incision tensioning clips 218. The tines 218a of the
incision tensioning clips 218 penetrate the graft vessel 220 in
order to secure the graft vessel 220 to the target vessel 202. Once
the tines 218a penetrate the graft vessel 220, the tines 218a
rotate or fold over, as indicated by directional arrows "C" and
"D", in order to secure the graft vessel 220 to the target vessel
202.
[0061] As previously mentioned with reference to FIG. 3A, a
predetermined force may form the incision 204 to the predetermined
length X. In accordance with one embodiment of the present
invention, a force controlled tension device 224, as shown with
respect to FIG. 14A, applies a predetermined force to the target
vessel 202 in order to form the incision 204 to the predetermined
length X. The force controller tension device 224 includes
tensioners 226 and 228. The tensioners 226 and 228 are configured
to engage the target vessel 202 with hooks 226a and 228a, as shown
with reference to FIG. 14A. It should be noted that the tensioners
226 and 228 may also be pins, or any other device suitable for
engaging the target vessel 202, as described earlier. Additionally,
the tensioners 226 and 228 include removable sections 226b and 228b
which allow for precise placement of the graft vessel 220 to the
target vessel 202. The removable sections 226b and 228b are removed
once the graft vessel 220 is placed over the removable sections
226b and 228b and the graft vessel 220 is brought into contact with
tensioners 226 and 228, as will be discussed more fully with
respect to FIGS. 15A and 15B.
[0062] In accordance with one embodiment of the present invention,
the tensioner 228 engages with the tensioner 226 via a notch 228c.
The notch 228c is configured such that the tensioner 228 slidably
attaches to the tensioner 226, as shown in the Figure. The force
controller tension device 224 also includes a spring 230 which
imparts a force on the tensioner 228 in order to separate the
tensioner 228 from the tensioner 226 upon insertion of the force
controller tension device 224 within the target vessel 202, as
shown with reference to FIG. 15A. The spring 230 may be any spring
suitable for separating the tensioner 228 from the tensioner 226,
such as a compression spring or the like. In accordance with one
embodiment of the present invention, the spring 230 imparts a force
preferably in a range of about 0.001 N to about 4.5 N and more
preferably about 0.65 N. It should be noted that alternative
techniques may be used to separate the tensioner 228 from the
tensioner 226 in addition to the spring 230 using any suitable
force applying mechanism, such as a torque applying DC motor or the
like.
[0063] Turning to FIG. 15A, FIG. 15A illustrates the insertion of
the force controller tension device 224 within the target vessel
202, in accordance with one embodiment of the present invention.
Prior to insertion within the target vessel 202, the tensioners 226
and 228 are adjacent to one another to form a single unit as shown
with reference to FIG. 14B. Upon insertion of the force controller
tension device 224 within the target vessel 202, the spring 230
moves the tensioner 228 in the direction Z in order to form the
incision 204 to the predetermined length X, as shown with reference
to FIG. 15B. In one embodiment of the present invention, once the
force controller tension device 224 forms the incision 204 to the
predetermined length X, the graft vessel 220 is placed over the
removable sections 226b and 228b. The removable sections 226b and
228b are then removed in order to allow grafting of the graft
vessel 220 to the target vessel 202 as shown with reference to FIG.
15B.
[0064] Now making reference to FIG. 16, FIG. 16 illustrates a
method 300 for tensioning an incision in a target vessel, in
accordance with one embodiment of the present invention. In an
operation 302, an incision is made in a target vessel. The incision
allows for grafting of a graft vessel to the target vessel during
an end to side anastomosis procedure. Once the incision is made in
the target vessel, incision tensioners are inserted into ends of
the incision in an operation 304. The incision tensioners may
include any structure suitable for providing tension to an
incision, including the previously described anvil, hooks, pins,
balloons and clips. For example, making reference to FIG. 3A, an
incision 204 is made in the target vessel 202 in the operation 302.
Once the incision is made, hooks 206a are inserted into the
incision. After insertion of the hooks 206a, an operation 306 is
performed.
[0065] In the operation 306, the incision tensioners pull the
incision taut. In one embodiment of the present invention, the
incision tensioners are considered taut when the incision is
tensioned to a predetermined length. It should also be noted that
when the incision tensioners are pulled taut, the tensioners
maintain a known geometry of the incision. Turning back to the
example and FIG. 3A, the hooks 206a are pulled taut until the
incision 204 is tensioned to the predetermined length X. As
previously stated, the predetermined length X allows for proper
grafting of a graft vessel to the target vessel during an
anastomosis procedure by matching the incision length to a graft
vessel size. Turning back to the method 300, once the incision
tensioners pull the incision taut, a graft vessel is grafted to the
target vessel at the incision site during an anastomosis procedure
in an operation 308. The performed anastomosis procedure which
connects the graft vessel to the target vessel may include
suturing, stapling, clipping and deploying an automatic anastomosis
device. Furthermore, the performed anastomosis procedure may
include RF tissue welding, laser tissue welding, adhesive
application, or other connecting methods.
[0066] Referring back to the example and FIG. 13, in one
embodiment, the graft vessel 220 is secured to the target vessel
202 using the incision tensioning clip 218, as shown with reference
to FIG. 13. As described earlier, the incision tensioning clip 218
includes the tines 218a and 218b which engage both the graft vessel
220 and the target vessel 202. Also as described earlier, the tines
218a and 218b are configured to rotate once the tines 218a and 218b
penetrate the vessels 202 and 220 in order to capture the target
vessel 202 and the graft vessel 220, as shown with respect to FIG.
13. Additional securing mechanisms, such as staples, clips or
tissue welding may be used to secure the edges of the incision to
the graft vessel to complete the anastomosis procedure. After the
operation 308 is performed, the method 300 is complete.
[0067] As may be appreciated, the present invention provides a
precise method for aligning a graft vessel to a target vessel in a
time efficient and cost efficient manner. The incision tensioners
maintain a known geometry for an incision during an anastomosis
procedure. Therefore, a surgeon may precisely graft a graft vessel
to a target vessel containing the incision. The present invention
is preferably used with a stapling anastomosis device or
anastomosis clips, such as incision tensioning clips, which obviate
the need for suturing during an anastomosis procedure. Therefore,
both the amount of time required to graft vessels and the attendant
costs are greatly decreased. Moreover, the present invention
greatly reduces the possibility of trauma to the patient due to the
reduced amount of time required to graft vessels.
[0068] The above are exemplary modes of carrying out the invention
and are not intended to be limiting. It will be apparent to those
of ordinary skill in the art that modifications thereto can be made
without departure from the spirit and scope of the invention as set
forth in the following claims.
* * * * *